New Drug for ED Wins FDA Approval

[steroid.com 1]

We're mostly men here on this forum and many over the age of 30 so I think ED issues are relevant. It's one, but not all, reasons why we are on TRT protocols.

Looks like a new PDE5i is now FDA approved and coming to market with some success. It has increased receptor selectivity and a shorter half-life than all other PDE5i's.

The biggest problem with "on demand" PDE5i's is just that; a man knows he must perform in giving time frame and if the man's head is thinking more about having to perform in a giving time frame the less successful the outcome. It's been a big complaint of Viagra and Levitra to some extent whose half life is in the 4 to 6 hour range.

Cialis (Tadalafil) on the other hand is still far superior in that respect; it has an 18 hour half life putting far less "on demand" pressure on a man; in other words it's more natural.

Still, for some men, this may be a nice new option!


New Drug for ED Wins FDA Approval
By Charles Bankhead, Staff Writer, MedPage Today
Published: April 27, 2012


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WASHINGTON -- The PDE-5 inhibitor class of drugs for erectile dysfunction gained its first new member in a decade with the FDA approval of avanafil (Stendra).

The FDA based its decision largely on results of three randomized, placebo-controlled clinical trials involving a total of 1,267 men with diagnosed erectile dysfunction.

After treatment for 12 weeks, men randomized to the PDE-5 inhibitor had significantly greater improvement in the three principal endpoints of erectile dysfunction, vaginal penetration, and successful intercourse.

"This approval expands the available treatment options to men experiencing erectile dysfunction and enables patients, in consultation with their doctor, to choose the most appropriate treatment for their needs," Victoria Kusiak, MD, of the FDA Center for Drug Evaluation and Research, said in a statement.

Increased receptor selectivity and a shorter half-life are the key features distinguishing avanafil from other members of the PDE-5 (phosphodiesterase type 5) inhibitor class: sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra).

Men take avanafil on an as-needed basis 30 minutes before sexual activity.

Investigators in one of the randomized trials reported that men achieved erections as soon as 15 minutes after taking the drug. The rate of erections sufficient for intercourse increased from less than 15% to as much as 57% with avanafil versus 27% with placebo.

According to the FDA, the most commonly reported side effects in clinical trials of avanafil were headache, flushing, nasal congestion, nasopharyngitis, and back pain. A 40-week extension study involving patients from two of the randomized trials showed no increase in the frequency or severity of adverse effects associated with avanafil.

The drug is marketed by VIVUS of Mountain View, Calif.

[lovbyts]

It's nice to have more choices for those who need it. It's nice to see how many people have no issues though after getting on HRT and getting their system working properly and no longer need these band-aid fixes like a Popsicle stick and duct tape. lol
Still more choices is good and help bring the price down. I think they should make the liquids and gels legal here also. I know in Asian countries they sell a lot of the gels and people really like it.

[HRTstudent]

this sounds like a fun study to be a participant in...